QA Specialist III

Role Overview: The Quality Assurance Specialist III ensures compliance and quality standards across aseptic manufacturing operations. Collaborating with Manufacturing, Quality Control, and Engineering teams, the role involves providing quality oversight, supporting production activities, maintaining cGMP compliance, and making quality-related decisions. Responsibilities include reviewing batch records, supporting investigations and deviations, conducting GMP documentation reviews, and supporting real-time quality decisions during manufacturing. The position requires gown qualification and on-floor QA support in classified environments. The specialist manages multiple projects, supports continuous improvement, and leads or assists with compliance initiatives. Qualifications & Skills: A bachelor's degree in a scientific or technical field and at least 5 years of experience in a cGMP-regulated environment are essential. Prior QA/QC experience in pharmaceutical or biologics manufacturing, knowledge of GMP regulations, and familiarity with aseptic environments are required. Strong critical-thinking, communication, technical writing, and multitasking skills are necessary, along with proficiency in relevant systems like Microsoft Office, TrackWise, DMS, SAP, or LIMS. Key Duties: Ensuring regulatory compliance, conducting walk-throughs, reviewing GMP documentation, supporting investigations, providing on-floor QA support, and managing multiple projects to uphold quality and compliance standards.